REGISTRATION AND TRADEMARK LICENSE AGREEMENT
EXHIBIT 10.4
REGISTRATION AND TRADEMARK LICENSE AGREEMENT
This REGISTRATION AND TRADEMARK LICENSE AGREEMENT (this “Agreement”) is made as of
November 7, 2007 between Lex Pharmaceuticals, Inc. (“Lex”), a Delaware corporation, and
XxxxxxXxxxx Pharmaceuticals, Inc., a Delaware corporation (“XxxxxxXxxxx”). Lex and
XxxxxxXxxxx are each referred to individually as a “Party,” and collectively as the
“Parties.”
Background Statement
XxxxxxXxxxx and Lex are Parties to an Asset Purchase Agreement, dated as of the date hereof
(the “Purchase Agreement”), and the Related Agreements (as defined in the Purchase
Agreement). Pursuant to the Purchase Agreement, XxxxxxXxxxx has conveyed certain assets to Lex,
including the trademarks, trademark applications and domain name set forth on Schedule A (the
“Marks”), the approved new drug application numbers 50-405 and 50-406 (including all
supplements and amendments thereto, the “Approved Registrations”) and Technical Data and
Technical Data Embodiments (as set forth in Section 2.1(a)(i) of the Purchase Agreement).
Pursuant to the Purchase Agreement, and subject to conditions set forth therein, Lex may purchase
from XxxxxxXxxxx investigational new drug application number 73,767 (including any approval thereof
and all supplements and amendments thereto, the “IND”) and Technical Data and Technical
Data Embodiments (as set forth in Section 2.1(a)(ii) of the Purchase Agreement and, together with
the Marks, Approved Registrations and IND, the “Rights”). The Parties desire that
XxxxxxXxxxx shall have a license to use the Rights and the Parties are entering into this Agreement
to set forth the terms and conditions of such license.
Statement of Agreement
1. Definitions.
1.1 Terms Defined in Purchase Agreement. Terms defined in the Purchase Agreement and
not otherwise defined by this Agreement shall have the meaning given to such terms in the Purchase
Agreement.
1.2 “Adverse Drug Experience” means the definition in the current 21 C.F.R. Section
314.80, as in effect from time to time.
1.3 “Agreement” has the meaning set forth in the introductory paragraph.
1.4 “Approved Registrations” has the meaning set forth in the Background Statement.
1.5 “Consignment Agreement” means the Inventory Consignment Agreement, dated as of the
date hereof, between Kef and XxxxxxXxxxx.
1.6 “Governmental Authority” means any nation or government, any state or other
political subdivision thereof, any municipal, local, city or county government, any entity
exercising executive, legislative, judicial, regulatory or administrative functions of or
pertaining to government.
1.7 “IND” has the meaning set forth in the Background Statement.
1.8 “Indemnitee” has the meaning set forth in Section 9.3.
1.9 “Indemnitor” has the meaning set forth in Section 9.3.
1.10 “Kef” means Kef Pharmaceuticals, Inc., a Delaware corporation.
1.11 “Kef Stock Purchase Agreement” means that certain Stock Purchase Agreement, dated
as of November ___, 2007, between XxxxxxXxxxx, the stockholders of Kef and Deerfield Management,
L.P., pursuant to which XxxxxxXxxxx has a right to purchase all of the capital stock of Kef upon
the terms and conditions set forth in such Stock Purchase Agreement.
1.12 “Kef Stock Purchase Right” means Stock Purchase Right as defined in the Kef Stock
Purchase Agreement.
1.13 “Lex” has the meaning set forth in the introductory paragraph.
1.14 “Lex Stock Purchase Agreement” means that certain Stock Purchase Agreement, dated
as of the date hereof, between XxxxxxXxxxx, the stockholders of Lex and Deerfield Management, L.P.,
pursuant to which XxxxxxXxxxx has a right to purchase all of the capital stock of Lex upon the
terms and conditions set forth in such Stock Purchase Agreement.
1.15 “Lex Stock Purchase Right” means Stock Purchase Right as defined in the Lex Stock
Purchase Agreement.
1.16 “License” has the meaning set forth in Section 2.1.
1.17 “Licensed Patents” has the meaning given to it the Patent Sublicense.
1.18 “Licensed Product(s)” means all dosage forms, formulations, strengths and package
sizes and types of any Cephalexin antibiotic products that may be marketed now or in the future
under the Rights.
1.19 “Marks” has the meaning set forth in the Background Statement.
1.20 “XxxxxxXxxxx” has the meaning set forth in the introductory paragraph.
1.21 “Minimum Royalty” has the meaning set forth in Section 3.2.
1.22 “Net Sales” shall mean, with respect to a Licensed Product, the gross amount
invoiced by or on behalf of XxxxxxXxxxx for that Licensed Product sold to third parties in bona
fide, arm’s length transactions, less customary deductions, determined in accordance with
XxxxxxXxxxx’x standard accounting methods as generally and consistently applied by XxxxxxXxxxx, to
the extent included in the gross invoiced sales price of any Licensed Product and otherwise
directly paid or incurred by XxxxxxXxxxx or distributors with respect to the sale of such a
Licensed Product, including: (i) applicable sales credits (as described below), (ii) payments or
rebates incurred pursuant to federal, state and local government (or agency thereof)
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programs, including Medicare and Medicaid rebates, (iii) costs for transit insurance, freight,
handling or other transportation billed to customers to the extent included in the invoiced price
and (iv) sales, use or excise taxes included in the invoiced price. Applicable sales credits
include credits or discounts deducted from the sales price for: (A) customer returns, returned
goods allowances, rejected goods and damaged goods not covered by insurance, (B) cash or terms
discounts, (C) direct to customer discount or customer rebate programs, including coupons, (D)
third party rebates and chargebacks, (E) trade show discounts and stocking allowances, (F) price
adjustments on customer inventories following price changes, (G) product recalls, (H) deductions
due for discount card programs, (I) amounts credited for uncollectible amounts on previously sold
products and (J) agreed by Lex and XxxxxxXxxxx in writing, other specifically identifiable amounts
included in gross sales of Licensed Products that were or ultimately will be credited and that are
substantially similar to those listed above.
1.23 “Party” means either XxxxxxXxxxx or Lex and “Parties” shall mean both
XxxxxxXxxxx and Lex.
1.24 “Patent Sublicense” means the Patent Sublicense that may be entered into between
Kef and XxxxxxXxxxx pursuant to that certain Asset Purchase Agreement, dated as of the date hereof,
between XxxxxxXxxxx and Kef.
1.25 “Person” means any corporation, administrator, association, joint venture,
partnership, limited liability company, organization, business, individual, trust, government or
agency or political subdivision thereof or other legal entity.
1.26 “Purchase Agreement” has the meaning set forth in the Background Statement.
1.27 “Regulatory Authority” shall mean any federal, national, multinational, state,
provincial or local regulatory agency, department, bureau or other governmental entity with
authority over the marketing, pricing and/or sale of a pharmaceutical product in a country,
including without limitation FDA in the United States.
1.28 “Regulatory Obligations” has the meaning set forth in Section 6.1.
1.29 “Regulatory Responsibilities Agreement” means the Agreement Regarding Regulatory
Responsibilities, dated as of the date of this Agreement, between Lex and XxxxxxXxxxx.
1.30 “Related Agreements” has the meaning set forth in the Background Statement.
1.31 “Rights” has the meaning set forth in the Background Statement.
1.32 “Royalty” has the meaning set forth in Section 3.
1.33 “Term” means the period beginning on the date hereof and continuing until the
License is terminated pursuant to the terms of this Agreement.
1.34 “Territory” means the United States of America and Puerto Rico.
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2. Grant of License.
2.1 Grant. Lex hereby grants to XxxxxxXxxxx, upon and subject to the terms and
conditions of this Agreement, an exclusive license under the Rights to develop, manufacture,
market, distribute and sell, and have manufactured, marketed, distributed and sold, the Licensed
Products in the Territory (the “License”).
2.2 Exclusivity. The License is exclusive as to all Persons, including Lex.
2.3 No Transfer. XxxxxxXxxxx shall not assign the License or grant any sublicense
under the License, other than (i) a sublicense to manufacture the Licensed Products solely for sale
by or on behalf of XxxxxxXxxxx or (ii) such sublicenses as may be necessary to continue the
development of, and to obtain marketing approval for, Licensed Products under the Approved
Registrations or the IND.
2.4 Obligation to Develop and Market. XxxxxxXxxxx shall at all times during the Term
use its commercially reasonable efforts, consistent with usual pharmaceutical industry practice, to
develop and commercialize the Licensed Products during the term of this Agreement. XxxxxxXxxxx’x
obligations under this Section 2.4 may be suspended for so long as there exists any material safety
(including toxicity), efficacy, regulatory, medical or intellectual property issue relating to the
Licensed Products.
3. Royalty. In consideration of the grant of the License, XxxxxxXxxxx shall pay Lex a
royalty (the “Royalty”) as follows:
3.1 Percent of Net Sales. The Royalty shall be equal to nine percent (9%) of
XxxxxxXxxxx’x Net Sales of Licensed Products plus such additional amount as may be necessary for
XxxxxxXxxxx to pay the Minimum Royalty.
3.2 Minimum Royalty. Regardless of the amount of Net Sales, the minimum Royalty
during any calendar quarter shall be Four Hundred Thousand Dollars ($400,000) (the “Minimum
Royalty”); provided, that any payments made by XxxxxxXxxxx to Kef during any calendar
quarter pursuant to the Consignment Agreement shall be included for purposes of determining whether
XxxxxxXxxxx has paid the Minimum Royalty for such calendar quarter. The Minimum Royalty shall be
pro-rated during the first and last calendar quarters of the Term to reflect the portion of such
calendar quarters during which the License is in effect.
3.3 Quarterly Payment. Within forty-five (45) days after the end of each calendar
quarter any part of which is during the Term, XxxxxxXxxxx shall deliver to Lex (i) a written
statement showing all Net Sales during such calendar quarter and (ii) the greater of (A) the
Royalty due upon such Net Sales and (B) the Minimum Royalty. All payments shall be made by wire
transfer of immediately available funds to an account designated by Lex.
3.4 Audit. Upon not less than seven (7) days written notice, Lex shall have the right
to audit the books and records of XxxxxxXxxxx relating to sales of Licensed Products for the
purpose of determining the correctness of XxxxxxXxxxx’x computation and payment of the Royalty.
Such audit may not be conducted more than once in any six-month period and shall be conducted
during normal business hours. Lex may engage an accounting firm at its cost to
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perform or assist in such audit. XxxxxxXxxxx shall provide Lex, its officers, agents and
accountants with access to all pertinent books and records and shall reasonably cooperate with
Lex’s efforts to conduct such audits.
4. Ownership of Rights. XxxxxxXxxxx acknowledges that, as between the Parties, Lex is
the sole and exclusive owner of the Rights, and XxxxxxXxxxx shall do nothing inconsistent with such
ownership. XxxxxxXxxxx shall not challenge Lex’s ownership and rights in or to any of the Rights
or assist others in challenging Lex’s ownership thereof. XxxxxxXxxxx agrees that nothing in this
Agreement shall give XxxxxxXxxxx any right, title or interest in the Rights other than the License
granted herein. Upon Lex’s request, XxxxxxXxxxx shall provide such information and assistance, and
execute and deliver such documents, as Lex may reasonably request for purposes of registering,
maintaining or enforcing any of the Rights.
5. No Warranty. The Parties acknowledge that (i) Lex has acquired the Rights from
XxxxxxXxxxx as of the date hereof on the basis of representations and warranties regarding the
Rights made by XxxxxxXxxxx for the benefit of Lex and (ii) pursuant to the Regulatory
Responsibilities Agreement, XxxxxxXxxxx shall be responsible for maintaining and performing all
Legal Requirements relating to the Rights. LEX MAKES NO REPRESENTATIONS OR WARRANTIES WHATSOEVER
REGARDING THE RIGHTS OR THE LICENSED PRODUCTS, AND XXXXXXXXXXX ACKNOWLEDGES THAT IT IS ACCEPTING
THE RIGHTS “AS IS” UNDER THE LICENSE.
6. Regulatory Obligations.
6.1 Performance by XxxxxxXxxxx. During the Term, XxxxxxXxxxx shall take all
reasonable and appropriate actions, at XxxxxxXxxxx’x sole cost and expense, to maintain the Rights
and shall oversee, monitor, coordinate and perform all regulatory actions, communications and
filings with and submissions, including filings and submissions of supplements and amendments
thereto, to each applicable Regulatory Authority or Governmental Authority with respect to each
Licensed Product (the “Regulatory Obligations”). Notwithstanding the foregoing, nothing
herein shall operate to prevent Lex from taking such actions as Lex, in its sole discretion, deems
appropriate to ensure that all Regulatory Obligations are properly and timely performed, subject to
prior notice to and consultation with XxxxxxXxxxx.
6.2 Regulatory Meetings and Correspondence. XxxxxxXxxxx shall be responsible for
interfacing, corresponding and meeting with the applicable Regulatory Authorities with respect to
each Licensed Product. Lex shall execute such notices, powers of attorney, acknowledgments,
consents and other instruments as XxxxxxXxxxx may reasonably request to authorize XxxxxxXxxxx to
act on Lex’s behalf for all actions before and communications with Regulatory Authorities, the
United States Patent and Trademark Office, other Governmental Authorities and with any designated
registrars of domain names, as shall be necessary and appropriate to enable XxxxxxXxxxx to perform
the Regulatory Obligations. Furthermore, as Lex’s agent for such Regulatory Obligations,
XxxxxxXxxxx shall have complete and sole discretion to take or not take such actions as it deems
reasonable and appropriate, provided that XxxxxxXxxxx shall comply with all Legal Requirements and
shall not cause, and shall use commercially reasonable efforts to prevent, the termination of any
of the Rights.
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6.3 Exchange of Information. The Parties shall establish procedures to ensure that
the Parties exchange on a timely basis all necessary information to enable XxxxxxXxxxx to comply
with all Regulatory Obligations, including, without limitation, filing updates, pharmacovigilance
filings and investigator notifications. To the extent either Party receives any information
regarding Adverse Drug Experiences related to the use of Licensed Products, such Party shall (i)
provide the other Party with such information within five (5) days of its receipt, (ii) promptly
provide all follow-up information that may reasonably be requested and (iii) otherwise act in
accordance with such Adverse Event Reporting Procedures to be agreed upon in writing by the Parties
from time to time. Without limiting the foregoing requirement, XxxxxxXxxxx shall provide Lex with
copies of all communications between XxxxxxXxxxx and any Governmental Authorities relating to any
of the Licensed Patents, Rights and Licensed Products, in every case within five (5) Business Days
of the sending or receipt of such communication by XxxxxxXxxxx.
6.4 Costs and Expenses. XxxxxxXxxxx shall bear all costs and expenses of performing
the Regulatory Obligations.
7. Infringement of Rights.
7.1 Conduct of Actions. If either Party shall receive notice of any infringement or
threatened infringement of any of the Rights, such Party shall immediately notify the other Party
of such infringement or threatened infringement, providing all information relating thereto
possessed by the notifying Party. With Lex’s consent, which shall not be unreasonably withheld,
XxxxxxXxxxx may initiate and control any legal action relating to infringement of any of the
Rights; provided, that (i) XxxxxxXxxxx shall keep Lex fully apprised of all activity in
such action, (ii) Lex shall have the right to participate in such action at its own expense, (iii)
XxxxxxXxxxx shall not take any position in such action inconsistent with Lex’s sole and exclusive
ownership of the Rights and (iv) no settlement of any such action shall be made without the consent
of Lex, which shall not be unreasonably withheld or delayed. In furtherance of such right, Lex
hereby agrees that XxxxxxXxxxx may include Lex as a party plaintiff in any such action and that Lex
shall cooperate, at the expense of XxxxxxXxxxx, in the prosecution of such action as reasonably
requested by XxxxxxXxxxx. Any monetary recovery in connection with such action shall first be
applied to reimburse XxxxxxXxxxx and Lex for out-of-pocket expenses (including attorneys’ fees)
incurred in prosecuting such action. Any remaining monetary recovery in such action shall be
equitably divided between the Parties on the basis of their respective damages resulting from the
claimed infringement. XxxxxxXxxxx shall bear all expenses of any such litigation, other than the
fees of any counsel Lex may engage if Lex chooses to participate separately in such action.
7.2 Action Initiated Against Lex. In the event that a declaratory judgment action
alleging invalidity or infringement of any of the Rights shall be brought against Lex, MiddleBrook,
at its option, shall have the right, within thirty (30) days after commencement of such action, to
intervene and take over the sole defense of the action at its own expense.
7.3 Cooperation. In any infringement action that either Party may institute to
enforce the Rights pursuant to this Agreement the other Party shall, at the expense of the Party
initiating such action, reasonably cooperate and, to the extent possible, have its applicable
employees
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testify when requested and make available relevant records, papers, information, samples,
specimens and the like.
8. Use of Marks; Product Quality. XxxxxxXxxxx shall use the Marks solely in
association with Licensed Products that satisfy all purity, manufacturing, packaging and quality
standards required by the United States Food and Drug Administration and other applicable law.
XxxxxxXxxxx shall comply with all Legal Requirements pertaining to the marketing, promotion,
distribution and sale of Licensed Products. XxxxxxXxxxx may use the Marks on the Licensed Products
in such form and manner as previously used by XxxxxxXxxxx, and shall notify Lex of any material
change in the form of the Marks use at least thirty (30) days prior to the commercial use thereof.
Lex’s approval of such a change shall be deemed granted unless Lex notifies XxxxxxXxxxx of its
disapproval and its reasons therefor within thirty (30) days of Lex’s receipt of such notice.
XxxxxxXxxxx shall materially conform to good manufacturing practices and shall obtain all necessary
and appropriate licenses, certifications and approvals from Governmental Authorities or private
certification agencies pertaining to the manufacture and sale of Licensed Products. Upon Lex’s
request, XxxxxxXxxxx shall provide Lex, at no charge, with samples of Licensed Products for
inspection and testing by Lex.
9. Indemnification; Insurance.
9.1 Indemnification by XxxxxxXxxxx. XxxxxxXxxxx shall defend, indemnify and hold
harmless Lex from and against all liabilities, losses, obligations, claims, judgments, awards,
relief, settlements, costs and expenses (including costs of any product recall and reasonable
attorneys’ fees, experts’ fees, investigation costs and other expenses of litigation) which Lex,
its shareholders, directors, officers, employees and representatives may suffer or incur arising
out of (i) the development, manufacture, marketing, advertising, sale or use by XxxxxxXxxxx,
directly or indirectly, of the Licensed Products, (ii) the exercise or use by XxxxxxXxxxx, directly
or indirectly, of any of the Rights, (iii) the performance or failure of performance by XxxxxxXxxxx
of the Regulatory Obligations, (iv) the exercise by XxxxxxXxxxx of any of the Rights after the
termination of the License thereof and (v) the breach by XxxxxxXxxxx of this Agreement.
XxxxxxXxxxx shall not be obligated to so indemnify, defend and hold harmless Lex to the extent that
any claim, expense, proceeding, demand or liability arises from the gross negligence or willful
misconduct of Lex.
9.2 Indemnification by Lex. Lex shall defend, indemnify and hold harmless XxxxxxXxxxx
from and against all liabilities, losses, obligations, claims, judgments, awards, relief,
settlements, costs and expenses (including costs of any product recall and reasonable attorneys’
fees, experts’ fees, investigation costs and other expenses of litigation) which XxxxxxXxxxx, its
shareholders, directors, officers, employees and representatives may suffer of incur arising out of
the breach by Lex of this Agreement. Lex shall not be obligated to so indemnify, defend and hold
harmless XxxxxxXxxxx to the extent that any claim, expense, proceeding, demand or liability arises
from the negligence or willful misconduct of XxxxxxXxxxx.
9.3 Procedure. A Party that intends to claim indemnification under this Section 9
(“Indemnitee”) shall promptly notify the other Party (the “Indemnitor”) of any
claim, damage, liability, cause of action or cost with respect to which the Indemnitee intends to
claim such
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indemnification. Indemnitor, after it determines that indemnification is required of it,
shall assume the defense thereof with counsel of its own choosing; provided, however, that
an Indemnitee shall have the right to retain its own counsel, with the expenses to be paid by
Indemnitor, if Indemnitor does not assume the defense. The agreement of indemnity contained in
this Section 9 shall not apply to amounts paid in settlement of any claim, damage, liability, cause
of action or cost if such settlement is effected without the consent of Indemnitor, which consent
shall not be unreasonably withheld. Indemnitor shall keep Indemnitee informed of, and consult with
Indemnitee in connection with, the progress of such litigation or settlement, and Indemnitor shall
not have the right, without Indemnitee’s written consent, to settle any such claim if such
settlement arises from or is part of any criminal action, suit or proceeding or contains a
stipulation to or admission or acknowledgement of, any liability or wrongdoing (whether in
contract, tort or otherwise) on the part of Indemnitee. The failure to deliver notice to
Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to
its ability to defend such action, shall relieve such Indemnitor of liability to the Indemnitee
under this Section 9 to the extent of such prejudice, but the omission to deliver notice to
Indemnitor will not relieve it of any liability that it may have to any Indemnitee otherwise than
under this Section 9. Indemnitee shall, and shall use commercially reasonable efforts to cause its
employees and agents to, cooperate reasonably with Indemnitor and its legal representatives in the
investigation and defense of any claim, damage, liability, cause of action or cost covered by this
indemnification.
9.4 Limitation of Liability. THE PARTIES AGREE THAT, NOTWITHSTANDING ANY OTHER
PROVISION HEREOF, NO PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE TO ANY OTHER PARTY OR ANY
OTHER PERSON OR ENTITY FOR DAMAGES IN THE FORM OF CONSEQUENTIAL, INCIDENTAL OR SPECIAL DAMAGES,
LOST PROFITS, LOST SAVINGS OR OTHERWISE, OR FOR EXEMPLARY DAMAGES, EVEN IF THE FIRST PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES; PROVIDED, HOWEVER, THAT THE FOREGOING
LIMITATION DOES NOT APPLY TO (I) ANY LOSS OF GOODWILL ASSOCIATED WITH THE MARKS DUE TO THE BREACH
OF THIS AGREEMENT BY EITHER PARTY, OR (II) ANY SUCH DAMAGES WHICH MAY BE PAYABLE TO A THIRD PARTY
BY A PARTY HERETO FOR WHICH SUCH PARTY IS INDEMNIFIED HEREUNDER.
9.5 Insurance. During the Term and for such longer period as XxxxxxXxxxx may be
selling any Licensed Products, XxxxxxXxxxx shall maintain general liability insurance under
customary pharmaceutical industry forms and endorsements, providing product liability and
contractual liability coverage, with per occurrence limits of not less than $10,000,000, which
limits may be achieved through a combination of underlying and excess policies. The insurance
policies described in the preceding sentence shall be endorsed to (i) name Lex as an additional
insured and (ii) to the extent permitted by Lex’s policies, be primary and non-contributory to any
insurance otherwise available to Lex. Upon the execution of this Agreement and at such times as
Lex may request thereafter, XxxxxxXxxxx shall cause the insurer(s) issuing such policy(ies) to
provide Lex with certificates of insurance evidencing the existence of such insurance, Lex’s status
as an additional insured and the primary and non-contributory nature of such policies with regard
to Lex. Such certificates of insurance shall provide that the insurer will notify Lex not less
than thirty (30) days prior to any expiration, non-renewal, cancellation, reduction in limits or
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exhaustion of limits of such insurance. XxxxxxXxxxx shall be responsible for any deductible
or self-insured amounts under any such insurance.
10. Termination.
10.1 Failure to Exercise Stock Purchase Right. Unless earlier terminated pursuant to
the terms of this Agreement, the License shall terminate upon the termination or expiration,
without exercise, of the Kef Stock Purchase Right.
10.2 Termination by Either Party. Each Party shall have the right, at any time during
the Term, to terminate this Agreement if:
(a) The other Party shall default in the performance of any of its material obligations
herein contained or in the Purchase Agreement, the Related Agreements, Patent Sublicense or
Consignment Agreement and such default has not been cured, or effective steps to cure such
default have not been initiated or are not thereafter diligently pursued, within sixty (60)
days (or such lesser period as may be required by any of this Agreement, the Purchase
Agreement, the Related Agreements, Patent Sublicense or the Consignment Agreement in
connection with a specific breach thereof) after receiving written notice thereof from the
non-defaulting Party specifying the default in reasonable detail; or
(b) The other Party shall cease to carry out its business, become bankrupt or
insolvent, apply for or consent to the appointment of a trustee, receiver or liquidator of
its assets or seek relief under any law for the aid of debtors.
10.3 Termination for Breach. Without limiting Sections 10.1 and 10.2, Lex shall have
the right to terminate the License if XxxxxxXxxxx shall (i) fail to pay any part of the Royalty
when due and shall fail to cure such non-payment within (A) fifteen (15) days after receiving
written notice if XxxxxxXxxxx has not exercised its Stock Purchase Right or (B) sixty (60) days of
receiving written notice of such non-payment from Lex if XxxxxxXxxxx has exercised its Stock
Purchase Right, unless the amount required to be paid is the subject of a good faith dispute
between the Parties and all undisputed amounts have been paid or (ii) fail to use commercially
reasonable efforts to perform in a correct and timely manner, or by any act or omission violate,
any material Regulatory Obligation, or by any act or omission violate any material Legal
Requirement relating to the Rights or the Licensed Products, and shall fail to cure such
non-performance or violation within fifteen (15) Business Days after receiving written notice of
such non-performance or violation from any source, or a lesser period of time if necessary to
satisfy any Legal Requirements.
10.4 Unauthorized Sublicense. For purposes of this Agreement, any attempted
assignment of the License or any grant of a sublicense under the License, except as authorized
pursuant to Section 2.3, shall be void and shall constitute a material breach of this License
including, without limitation, for purposes of this Section 10.
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11. General Provisions.
11.1 Amendment; Waiver. This Agreement, including the Schedules hereto, may be
amended, modified or supplemented only by an agreement in writing signed by the Parties. No course
of dealing between the Parties or failure by a Party to exercise any right or remedy hereunder
shall constitute an amendment to this Agreement or a waiver of any other right or remedy or the
later exercise of any right or remedy.
11.2 Force Majeure. No Party shall be responsible to any other Party for any failure
or delay in performing any of its obligations under this Agreement or for other nonperformance
hereof if such delay or nonperformance is caused by fire, flood, accident, act of God or of the
government or any country or of any state or local government, or of the public enemy of either, or
by cause unavoidable or beyond the control of such Party. In such event, the Party affected will
use reasonable commercial efforts to resume performance of its obligations.
11.3 Headings. The headings of Articles and Sections of this Agreement are for
convenience of reference only and shall not affect the meaning or interpretation of this Agreement
in any way. This Agreement shall be binding upon and inure to the benefit of the Parties hereto
and their respective successors and assigns.
11.4 Notices. All notices, consents, waivers and other communications hereunder shall
be in writing and shall be (i) delivered by hand, (ii) sent by facsimile transmission or (iii) sent
by a nationally recognized overnight delivery service, charges prepaid, to the address set forth
below (or such other address for a Party as shall be specified by like notice):
| If to Licensee, to: | XxxxxxXxxxx Pharmaceuticals, Inc. | |||
| 00000 Xxxxxx Xxxxxxx Xxxxxxx | ||||
| Xxxxxxxxxx, Xxxxxxxx 00000 | ||||
| Attention: Xxxxxx X. Xxxxxx, Ph.D. | ||||
| Facsimile: (000) 000-0000 | ||||
| Copy to: | Xxxxx & XxXxxxx LLP | |||
| 0000 Xxxxxx xx xxx Xxxxxxxx | ||||
| Xxx Xxxx, Xxx Xxxx 00000 | ||||
| Attention: Xxxxxxxxx X. Xxxxxx, Esq. | ||||
| Facsimile: (000) 000-0000 | ||||
| If to Licensor, to: | Kef Pharmaceuticals, Inc. | |||
| 000 0xx Xxxxxx, 00xx Xxxxx | ||||
| Xxx Xxxx, Xxx Xxxx 00000 | ||||
| Attention: Xxxxx X. Xxxxx | ||||
| Facsimile: |
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| Copy to: | Xxxxxxxx, Xxxxxxxx & Xxxxxx, P.A. | |||
| 000 Xxxxx Xxxxx Xxxxxx, Xxxxx 0000 | ||||
| Xxxxxxxxx, Xxxxx Xxxxxxxx 00000 | ||||
| Attention: Xxxxx X. Xxxxx | ||||
| Facsimile: (000) 000-0000 |
Each such notice or other communication shall be deemed to have been duly given and to be effective
if (A) delivered by hand, immediately upon delivery if delivered on a Business Day during normal
business hours and, if otherwise, on the next Business Day, (B) sent by facsimile transmission,
immediately upon confirmation that such transmission has been successfully transmitted on a
Business Day before or during normal business hours and, if otherwise, on the Business Day
following such confirmation, or (C) sent by a nationally recognized overnight delivery service, on
the day of delivery by such service or, if not a Business Day, on the first Business Day after
delivery. Notices and other communications sent via facsimile must be followed by notice delivered
by hand or by overnight delivery service as set forth herein within five (5) Business Days.
11.5 Assignment; No Third Party Rights. This Agreement and all of the provisions
hereof shall be binding upon and inure to the benefit of the Parties and their respective
successors and permitted assigns. This Agreement may not be assigned by XxxxxxXxxxx without the
prior written consent of Lex, which consent shall not be unreasonably withheld. Notwithstanding
the preceding sentence, after the exercise of the Kef Stock Purchase Right, XxxxxxXxxxx may assign
this Agreement along with its entire business. Lex may assign this Agreement to any Person who
receives an assignment of Lex’s interest in the Purchase Agreement and the Related Agreements.
This Agreement and its provisions are for the sole benefit of the Parties and their successors and
permitted assigns and shall not give any other Person any legal or equitable right, remedy or
claim.
11.6 Governing Law; Venue. The execution, interpretation and performance of this
Agreement, and any disputes with respect to the transactions contemplated by this Agreement,
including any fraud claims, shall be governed by the internal laws and judicial decisions of the
State of New York, without regard to principles of conflicts of laws.
11.7 Severability. If any provision contained in this Agreement shall for any reason
be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other provision of this Agreement, and this Agreement shall
be construed as if such invalid, illegal or unenforceable provision had never been contained
herein, unless the invalidity of any such provision substantially deprives either Party of the
practical benefits intended to be conferred by this Agreement. Notwithstanding the foregoing, any
provision of this Agreement held invalid, illegal or unenforceable only in part or degree shall
remain in full force and effect to the extent not held invalid or unenforceable, and the
determination that any provision of this Agreement is invalid, illegal or unenforceable as applied
to particular circumstances shall not affect the application of such provision to circumstances
other than those as to which it is held invalid, illegal or unenforceable.
11.8 Construction. Each Party acknowledges that it and its attorneys have been given
an equal opportunity to negotiate the terms and conditions of this Agreement and that any rule of
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construction to the effect that ambiguities are to be resolved against the drafting Party or
any similar rule operating against the drafter of an agreement shall not be applicable to the
construction or interpretation of this Agreement.
11.9 Related Agreement. This Agreement, including the Purchase Agreement and Related
Agreements, appendices, schedules and exhibits thereto, are intended to be construed as parts of a
group of related transactions and shall be construed accordingly.
11.10 Counterparts. This Agreement may be executed in multiple counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument. This Agreement may be executed on signature pages exchanged by facsimile, in which
event each Party shall promptly deliver to the others such number of original executed copies as
the other Party may reasonably request.
11.11 No Joint Venture. The relationship between the Parties hereto is that of
independent contractors. Such Parties are not joint venturers, partners, principal and agent,
master and servant, employer or employee, and have no relationship other than as independent
contracting parties. Neither Party shall have the power to bind or to obligate the other in any
manner.
[Signatures are on the following page.]
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IN WITNESS WHEREOF, the Parties are entering into this Registration and Trademark License
Agreement as of the date first above written.
| LEX PHARMACEUTICALS, INC. | ||||||
| By: | /s/ Xxxxx X. Xxxxxxxx | |||||
| Name: Xxxxx X. Xxxxxxxx | ||||||
| Title: President | ||||||
| XXXXXXXXXXX PHARMACEUTICALS, INC. | ||||||
| By: | /s/ Xxxxxx X. Xxxxxx | |||||
| Name: Xxxxxx X. Xxxxxx, Ph.D. | ||||||
| Title: President and Chief Executive Officer | ||||||
